When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
The BioProduction Division (BPD) is one of the fastest growing businesses in the company and is driving performance in bioprocessing through collaboration with our customers. Our newly acquired Advance Bioprocessing site in Detroit, MI will enable our biopharmaceutical customers to bring new and innovative drugs to market faster.
How will you make an impact?
As the Quality Site Manager, you’ll be responsible for ensuring Quality Management and Regulatory Compliance for the site. You’ll leverage your transformational leadership skills to drive the integration efforts and identify synergies to leverage systems and resources within the organization while driving harmonization with local and corporate Quality Systems.
What Will You Do?
Develop and execute the Quality Strategic Plan for the Detroit site and assure balance of resource allocation, dollars, and equipment to deliver the plan.
Lead, coach and mentor the Quality team to ensure that the goals of the Quality Strategic Plan are accomplished.
As a member of the Site Leadership team, you’ll champion interdisciplinary team work and foster a culture of collaboration. You’ll influence and educate appropriate groups on new systems and processes and recommend modifications to local Quality policies, procedures, and practices that can affect the business.
Adhere to ISO Quality standards, cGMP requirements, and safety policies. You’ll also review and implement procedures for a safe, clean Quality work environment and will be the Quality representative to ISO, external customers, and outside agencies concerning audits.
Continually seek to develop and integrate methods of cost and quality improvement using continuous improvement tools.
How will you get here?
Bachelors Degree is required
A minimum of 9 years of experience
A minimum of 4 years of leadership experience with the demonstrated ability to lead, motivate, and accomplish results.
Knowledge, Skills and Abilities
Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR Part 11 and 21 CFR Part 820.
Working knowledge and understanding of the International Organization for Standardization (ISO) 9000/9001 and 13485
Ability to organize and prioritize assignments providing direction to assigned functional teams.
Ability to communicate with clarity and manage conflict resolution in a variety of settings; one-on-one interactions, group meetings, and formal presentations.
Ability and skill to effectively manage multiple tasks and lead execution of change management plans.
Ability and skill to lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and execution, continuous improvement projects using statistical sampling, six sigma root cause analysis tools, and project management techniques.
Ability to act as a liaison across functions and with outside customer representatives or stakeholders concerning operational or project schedules/deliverables, audits, etc.
Able to manage budgets and develop capital expenditure requests.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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